Evaluation of QDOT MICRO catheter for pulmonary vein isolation (PVI) in subjects with Paroxysmal Atrial Fibrillation (PAF) (Q-fficiency)

Brief description of study

The purpose of this study is to provide information about the safety and long-term effectiveness (how well something works) of the QDOT MICRO™ Catheter for the treatment of subjects with Paroxysmal Atrial Fibrillation (PAF). The QDOT MICRO™ Catheter is an investigational device that has not been approved by the US Food and Drug Administration (FDA) for the treatment of PAF. The QDOT Micro catheter uses 2 modes of energy delivery to the tissue- a standard mode and a high energy short duration mode. It also has novel technology that precisely measures the temperature at the tip of th catheter and very small electrodes at the tip that can pick very fine signals from the heart. Atrial fibrillation (AF) is the most common sustained arrhythmia in humans. It is caused by abnormal electrical signals in the upper chambers of the heart, called the atria, which cause them to beat rapidly and irregularly. This leads to ineffective pumping of blood by the atria. Although AF is usually not a lifethreatening condition, it can cause many symptoms such as palpitations, chronic fatigue and weakness, shortness of breath, and pain. It also may increase the risk of having a stroke.

Clinical Study Identifier: s18-01950
ClinicalTrials.gov Identifier: NCT03624881

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